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FDA 510(k)

ELEOS Limb Salvage System with BioGrip

K-Number: K203815 · 2021-06-09

ApplicantOnkos Surgical
Decision Date2021-06-09
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELEOS Limb Salvage System with BioGrip is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2021-06-09 under 510(k) number K203815. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEOS Limb Salvage System with BioGrip?

ELEOS Limb Salvage System with BioGrip is a medical device that received FDA 510(k) clearance on 2021-06-09. The listed applicant is Onkos Surgical. The 510(k) number is K203815.

When did ELEOS Limb Salvage System with BioGrip receive FDA 510(k) clearance?

ELEOS Limb Salvage System with BioGrip received FDA 510(k) clearance on 2021-06-09, under 510(k) number K203815.

Who is the listed applicant for ELEOS Limb Salvage System with BioGrip?

The FDA 510(k) record lists Onkos Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEOS Limb Salvage System with BioGrip?

The FDA product code for ELEOS Limb Salvage System with BioGrip is JDI.

Other records listing Onkos Surgical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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